Harvard Medical Area Page 1 of 35Protocol #
Revised 10/4/2013


Harvard Medical Area (HMA) Standing Committee on Animals – “Established in 1907”
180 Longwood Avenue, Suite 113Boston, MA02115 Tel: 617-432-3192 Fax: 617-432-3169

ANIMAL EXPERIMENTATION PROTOCOL

Principal Investigator
Harvard Appointment Title
Department
Address
HMA phone
FAX phone
Home phone
E-Mail Address
Contact Person
Contact Phone & Email
BIDMC PI Check here: / BIDMC investigators must send an approved copy of this protocol to BIDMC, East Campus, RN150D
Protocol Title
Funding Source
Grant Number & Title

Check one:

New Protocol / Three Year Review of Existing Protocol
This proposal has been reviewed and approved by the HMA Standing Committee on Animals
HMA Standing Committee on Animals Date:

Table of Contents

Sections listed in BOLD must be completed for every protocol.

Sections F through N are to be completed only as they apply to your protocol.

HCCM’SMANDATORY RISK DISCLOSURE (MRD)

A.ANIMAL USAGE

B.PROCEDURES

C.PERSONNEL

D.HOUSING/PROCEDURE LOCATION

E.DISPOSITION OF ANIMALS

F.IMMUNIZATION

G.ASCITES PRODUCTION

H.TRANSGENIC/KNOCKOUT ANIMALS

I.ADMINISTERED SUBSTANCES

J.SURGERY

K.MULTIPLE SURVIVAL SURGERY

L.PAINFUL PROCEDURES

M.BEHAVIORAL CONTROLS, RESTRAINT, OR ANALYSIS OF BEHAVIOR

N.DIET AND OTHER ENVIRONMENTAL CHANGES

O.DRUG AND SURGICAL SUPPLY MANAGEMENT PLAN

P.ALTERNATIVES TO PAIN AND DISTRESS

Q.MINIMIZATION OF DISCOMFORT, PAIN AND DISTRESS

R.DUPLICATION OF RESULTS

S.PROTOCOL PERSONNEL SIGNATURE PAGE

MRD: MANDATORY RISK DISCLOSURE - Hazardous substance disclosure sheet

STOP

YOU MUST RECORD AND CHECK OFF THE FOLLOWING PERTAINING TO YOUR SUBMITTED PROTOCOL: FAILURE TO DO SO WILL RESULT IN A DELAY IN PROTOCOL APPROVAL

Note- items checked below must correspond with the information provided in your protocol.

**MUST CHECK (X) ALL THAT APPLY**
Check: / Procedures: / Identify specific agent(s): / Route(s):
Chemical carcinogen(s)
Toxic substance(s)
Radioisotope
license #:______
Microbiological Agent(s)
COMS/PIBC #: ______
Provide Biosafety Level next to each agent
Human or NHP cell line(s) or tissue(s)
COMS/PIBC #: ______
Non-human animal cell line(s) or tissue(s)
Other (must specify)
NONE OF THE ABOVE
This box must be checked if none of the above agents apply to your work described in this protocol.
By checking this box & signing below you are emphatically stating that you are NOT using any of the above in research animals.

Note: YOU MUST NOTIFY THE HCCM WHEN YOU BEGIN WORK WITH THESE AGENTS. Contact the HCCM Coordinator of Special Projects via phone at:
617-432-4658 or mailto:

PI must print and sign below (mandatory; a proxy will not be accepted):

P.I. Name ______P.I. Signature ______Date __/__/__

Introduction

The Harvard Medical School Standing Committee on Animals was established in 1907 almost 60 years prior to the Animal Welfare Act. This Committee charter states: A Committee of at least five, which has the power to inspect the animal rooms at any time, to issue orders and regulations they may deem fit for the proper care and feeding of animals, to discharge any employee of the school who in any way treats animals with cruelty, to dispose of any animal which is in any way objectionable and to determine the sources from which animals are to be obtained. This Committee shall also have general power to stop any experimental work on animals that they may consider improper or unnecessary. This charter is still in effect today and the Committee, appointed by the Dean for Academic and Clinical Programs, continues to have the authority as described.

The Committee members today include scientists, veterinarians, and lay representatives. This Committee is committed to the continued use of animals in research within the constraints of humane treatment as viewed by society. To justify approval of procedures, the Committee must have adequate written information regarding the steps taken to assure humane treatment of animals. Present your material clearly and concisely. Lay members of the Committee must be able to understand this protocol.

The Animal Experimentation Protocol (AEP) MUST include a FLOW CHART AND a written description of the procedures outlined in Section B.2. Failure to comply will result in delay of approval for an additional month.

  • PIs are encouraged to send any new protocols and amendments as soon as the PI completes a reasonable draft. Submissions that have undergone a veterinary review at least two weeks before a scheduled IACUC meeting will be reviewed at such meeting, via Full Committee Review (FCR). Otherwise they will be reviewed at the next scheduled meeting, or via Designated-member Review (DMR).
  • Three-year renewals are due to the IACUC no later than 60 days prior to their expiration date in case the protocol needs to be re-reviewed at a subsequent full committee meeting. Otherwise there is risk of research interruption if any required modifications are not satisfactorily addressed prior to the protocol expiration date. Early submission helps ensure that there is no lapse in approval and that research continues uninterrupted.
  • Submission deadline and address for NEPRC protocol documents

DEADLINE FOR SUBMISSION OF NEW PROTOCOLS, AND 3-YEAR RENEWAL OF PROTOCOLS is the 15th of the month (or the end of the next business day, if the 15th falls on a weekend or holiday), of the month PRIOR to the IACUC meeting (e.g. due on April 15th, for consideration at the May IACUC meeting). Submissions must be sent to . Protocols for animal studies performed at the New England Primate Research Center must be reviewed first by the Animal Research Resources Committee (ARRC). Following a successful ARRC review, the ARRC will forward all submissions to the IACUC office for review at the following IACUC meeting.

  • Submission address

Non-NEPRC submissions and scanned signature pages should be sent electronically to: (MS Word format only).

  • Accessing protocol forms

Current forms and supplemental information can be found at:

A.ANIMAL USAGE

1.Checklist – animal usage PER YEAR

  • Place an “X” next to the procedures you will be performing.
  • Enter the total number of animals in each category as well as the total number in multiple categories.
  • Complete a separate ‘Checklist’ for each species.
  • Complete a search for alternatives for each procedure in Category D and/or E

Species / # Used per year
CATEGORY B -Teaching, research, or tests that involve breeding or housing of animals only
Breeding colony
Housing ONLY (no other procedures)
Total number of animals to be used in Category B only
CATEGORY C -Teaching and/or research experiments that do not involve more than momentary pain and/or distress or require the use of pain relieving drugs.
Alert animals (behavioral observation or brief restraint)
Anesthetize and release for non-invasive procedures (e.g. imaging, bandage change)
Change in environmental parameters (diet, light cycle, room temperature, etc.)
Chemical carcinogens (e.g. BrdU)
Euthanasia with or without tissue/organ harvest
Forced exercise
Gavage
Irradiation
Microbiological agents
Non-surgical collection of body fluids (blood, urine, etc.)
Radioisotopes
Simple injections (IP, IV, etc.)
Tail biopsy for genotyping (mice under 21 days)
Use as a parasitic host
Total number of animals to be used in Category C

Note: For all procedures in Categories D & E (below) a search must be completed inSection P

CATEGORY D – Teaching and/or research experiments or tests that will involve pain and/or distress and for which appropriate anesthetic, analgesic or tranquilizing drugs will be used.
Anesthetize and release for non-surgical painful procedures (e.g. retro-orbital bleeds)
Antibody production:ascites
Antibody production: polyclonal (non-ascites, no footpad)
Burns
Controlled drugs or substances (as test material, e.g. cocaine)
Electric shock
Food or water deprivation other than pre-surgical fasting
Footpad injections (antibody production or microorganism)
Introduction of illness (including the administration of toxins, microbiological agents, clinical transgenic phenotypes)
Lavage
Multiple MAJOR survival surgery
Multiple MINOR survival surgery
Non-survival surgery
Physical trauma
Survival surgery: MAJOR
Survival surgery: MINOR
Tail biopsy for genotyping (mice over 21 days)
Toxic substances (e.g. streptozotocin, MPTP, cisplatin, doxycycline)
Transgenic mouse production (embryo manipulations to produce novel strains, etc.
Tumor induction or implantation
Unusual or prolonged restraint (e.g. pie chamber, chair)
Use of paralytic agents
Total number of animals to be used in Category D
CATEGORY E – Teaching and/or research experiments, surgery or tests that involve PAIN and/or DISTRESS, and for which appropriate anesthetic, analgesics or tranquilizing drugs are NOT used because they would adversely affect the results or interpretation of data.
Death-as-an-endpoint* studies
Lethal dose studies*
Noxious stimuli from which there is no escape
Pain study
Withholding of post-operative analgesia for any surgical procedure
Total number of animals to be used in Category E

*You must follow the Guidelines for ‘Death as an Endpoint’ or ‘Lethal Dose’ studies at:

EXCEPTIONS to STANDARDS – Select any policy deviations that will be required in this protocol. Scientific justification must be included in the indicated section of the protocol and/or separate exemption form.
Single housing of animals / Section D.4
Withholding of enrichment from singly housed animals / Section D.4.c
Euthanasia methods that are not consistent with the AVMA Guidelines / Section EExemption
Ascites collection / Section GExemption
Non-pharmaceutical grade drugs and other compound suspensions / Section I.7
Withholding postoperative analgesia** / Section J.2.kExemption
Food/water withholding or scheduling (not ad-lib) / Section N
Smaller caging than the recommended space allotment (e.g.: CLAMS) / Exemption form
Deviations from housing density standards / Exemption form
Toe-clipping for identification purposes / Exemption form
Deviations from the 12/12 hour light/dark cycle / Section N
Any other exceptions to the standards of the PHS Policy, the Guide, or the AWA. - Please specify: / Exemption form

**see also:

2.JUSTIFICATION FOR THE USE OF ANIMALS

Federal Assurances: You are required by federal law to provide the following justifications.

a.Why are animals needed for this study?(i.e.: Could the same information be obtained by experiments using tissue culture or computer models? If you are generating antibodies, could you use in vitro methods?)
b.Justify choice of each species:
c.Justify the number of animals to be used:(You must convince the Committee that the number of animals is appropriate to the work being proposed. Provide groups and statistical analysis to be used if relevant.)
d.Discuss your strategy to reduce the number of animals and to minimize pain and distress to your animals:(examples include: earlier euthanasia, decreasing the number of time points, changing the methods to those that are less invasive):
e.Breeding Colony users only: The estimated numbers of animals in breeding colonies must be provided and justified. These numbers must be also be tracked on a log sheet in the animal housing room.
  1. Estimated number of breeding adults:

  1. Estimated number of offspring produced:

  1. Estimated total number of offspring euthanized without research use:

  1. Criteria for offspring euthanized without research use:

f.NHP users only: Are the requested animals naïve in terms of experimental procedures? Yes____No____
If NO, submit the approval for reuse summary from the Animal Procurement, Allocation,and Reuse Committee .

B.PROCEDURES

  • Briefly describe the procedures to be conducted on animals. State the aims and significance of your experiments. Do not include in vitro work done on tissue taken from the animal, nor post-mortem procedures or analysis.
  • For 3-year reviews, incorporate all procedures listed in approved amendments in the past three years, if applicable. All amendments expire at the protocol 3-year renewal date.
  • Use language that can be readily understood by investigators and lay persons not familiar with your specific field of research and by non-scientists. Avoid or explain all acronyms.
  • Note: AEP submissions receive veterinary review prior to final submission to, and consideration by the IACUC. Veterinary pre-review and addressing veterinary comments do not guarantee Committee approval.

1. Aims and Significance:Provide a brief lay summary, no more than one page, describing your research. Do not include an excerpt from your grant proposal.
2. Procedures and manipulations:in lay terms, provide a short description of each animal procedure and manipulation (including changes in light cycle, alteration of feeding, etc. DO NOT include details of in vitro work). For SURGERY, state ONLY the name of the procedure in this section. Describe the surgery in detail only in Section J
3.FOR 3-YEAR REVIEWS:
  1. Progress Report: Briefly describe your RESULTS from the past 3 years and explain how the present application continues this work:

  1. For USDA-covered species (not mice, rats, or birds), describe any unexpected animal deaths in the course of your experiments:

  1. List publications and meetings in the past three years:

  1. Changes (briefly summarize any CHANGES in the protocol in the past three years, i.e. species, numbers, procedures, etc.):

FOR ALL (NEW and 3-YEAR Review) protocols

4.FLOWCHART - you must diagram your procedures in a flowchart

  • Present your experiments in a flowchart format (as opposed to a table, grid, or paragraph).
  • Show the schedule for the animal procedures in your flow chart, including the time points when the animals will be euthanized, if applicable.
  • Include animal numbers
  • For guidelines on creating your flowchart clickhere.
  • USDA covered species users note: This flowchart will be included with the medical record of each animal.

Present your flowchart here:

C.PERSONNEL

1. Will the principal investigator perform the procedure(s)?Yes____No____

2. Personnel List:

  • Provide the name(s), title(s) and qualifications for each person, including the PI, who will work with the animals.
  • Include the number of years and experience working with the species listed in Section A (Checklist) above.
  • If the person needs to be trained, indicate who will do the training.
  • NOTE - ALL current personnel must sign the last page of this form, Section S to gain access to the facilities.NEPRC clinical staff members that do not have substantial, direct, intellectual contributions to the workdonot need to be listed or sign this form unless they are the PI but must sign a confirmation compliance statement annually.
  • If this is a three year renewal protocol: The list below will replace all current lab personnel. Any additional personnel must be added via a personnel form, after renewal.

Name / Title/Job Classification / Qualification/ Experience / Phone / Email Address
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

3. PersonnelTraining:

ALL PERSONNEL HANDLING ANIMALS MUST BE TRAINED IN THEIR HUMANE CARE AND USE.
Records of personnel training must be maintained by the lab.

State the building and room number where training records for lab personnel will be stored:

All animal users are required to complete the following AALAS Learning Library (ALL) modules before they can be listed on an animal experimentation protocol:

  • “Working with the IACUC: Non-VA version” (All researchers)
  • “Safe Use of Toxic or Hazardous Materials in Animals” (NEPRC researchers should contact NEPRC for this training)
  • “Working With BL2-N Infectious Agents in Animals” (NEPRC researchers should contact NERPC for this training)

The ALLcan be accessed online at any time and courses can be completed from any location.

Follow these steps to access the ALL:

•Go to

•Click on ‘Enroll now!’ or log in to a previously created account

•Click on ‘Enroll as an Individual in a Group’

•Enter Access code: 20045HMAIACUC

•Set up your account and complete your enrollment (Institutional ID is your personal ID card number)

•To begin the courses, click on the ‘Libraries’ tab on along the top of the page and select the ‘Animal Care and Use Courses Library’ – you will then see a list of ‘AALAS Tracks’.

•From the middle of the list, select ‘HMA IACUC Courses’

•Begin reading the lessons. When done, take the exams.

•Upon successful passage of each exam, you may print out a certificate showing that you successfully completed the course (click on ‘Subscriber Center’, the tab on the far right along the top, and then select ‘Personal Access’, then click on ‘My Transcript’).

D.HOUSING/PROCEDURE LOCATION

  1. Where will your animals be housed?

Species / Building (Circle or boldface one) / Room #
WAB HSPH2 THORN HIM NEPRC NRB
SGMB MCP 65 Landsdowne 180 Longwood
WAB HSPH2 THORN HIM NEPRC NRB
SGMB MCP 65 Landsdowne 180 Longwood

For all research using rodents, indicate the level of biosecurity that you require.
Specific-pathogen-free (SPF) facilities are free from infection with a defined panel of infectious agents. These areas ONLY house animals from approved vendors or those animals that have undergone HCCM quarantine. Animals in SPF facilities are maintained so as to prevent infection and undergo regular serologic surveillance to assure SPF status. Non-SPF facilities may harbor one or more of these pathogens.

Species / SPF / Non-SPF / BL2/BL3
  1. Location of your animals:

a.Provide the area(s) where your animal procedures will be performed, including euthanasia.

Species / Building / Room # / Planned procedures / Time in this area**

**Animals may not remain in a lab for more than 12 hours,
nor may they be housed in the lab overnight, without express approval from the IACUC.

b.Please check situations or locations to which you plan to transport animals:

BWH SAIL
MRI at 221 Longwood- clinical magnet
(training and certification for use of human magnet required)
BIDMC LSAIF
BIDMC MRI (Non-LSAIF)
MGH/Charlestown
Transport of BL2 infected animals
(specify origin and destination)
Transport to any other institution (specify)*
None of the above

*Animal transport to any other institution requires submission of an approved IACUC protocol from that institution.

c.Please describe the associated transport plan:

  1. Identification of your animals:

a. Specify the manner in which you identify your animals:

Species / Identification Method(Circle or boldface one)
Ear notching/clipping Ear tagging Tattooing Banding
Vendor-placed tag or tattoo *Toe Clipping Micro-chipping Other (Specify)
Ear notching/clipping Ear tagging Tattooing Banding
Vendor-placed tag or tattoo *Toe Clipping Micro-chipping Other (Specify)

b. Describe the details of your method for identifying your animals: